GROMMET INSERTION 18 YEARS AND UNDER PERSISTENCE OF BILATERAL OTITIS MEDIA WITH EFFUSION SECONDARY CARE PRIOR APPROVAL POLICY

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1 SECONDARY CARE PRIOR APPROVAL POLICY Version: 1718.v3 Ratified by: Date Ratified: 05 April 2017 Name of Originator/Author: Name of Responsible Committee/Individual: Somerset CCG Clinical Commissioning Policy Forum (CCPF) IFR Manager CCPF Date issued: 18 April 2017 Review date: Target audience: Earliest of either NICE publication or 3 years from issue SCCG Web Site IFR Page SCCG Contracts Team Somerset CCG GP Practices via the GP Bulletin Medical Directors: Taunton & Somerset NHS FT Yeovil District Hospital NHS FT RUH Bath NHS FT UHB NHS FT Weston Area Health NHS Trust

2 SECONDARY CARE PRIOR APPROVAL POLICY CONTENTS Section Page VERSION CONTROL 1 GENERAL PRINCIPLES 2 BACKGROUND 2/3 CRITERIA 4 REVIEW 5 MONITORING, COMPLIANCE AND EVALUATION ASSOCIATED DOCUMENTS Appendices APPENDIX 1 Use Title Case

3 SECONDARY CARE PRIOR APPROVAL POLICY VERSION CONTROL Document Status: Current policy Version: 1718.v3 DOCUMENT CHANGE HISTORY Version Date Comments 1516.v2 March 2017 Amend remove age 3 years include 18 years and under clarify the criteria Equality Impact Assessment (EIA) Form OR EIA Screening Form completed. Date: In progress Sponsoring Director: Sandra Corry Author(s): Document Reference: 1718.v3 1

4 Grommet Insertion for 18 years and under is not routinely funded by the CCG And is subject to this restricted policy General Principles Funding approval will only be given in line with these general principles. Where patients are unable to meet these principles in addition to the specific treatment criteria set out in this policy, funding approval will not be given. 1. The Prior Approval funding approval must be secured by secondary care prior to treatment/surgery. 2. CCG does not commission surgery for cosmetic purposes alone. 3. Funding approval must be secured by primary care/secondary care prior to referring/treating patients seeking corrective surgery. 4. On limited occasions, the CCG may approve funding for an assessment only in order to confirm or obtain evidence demonstrating whether a patient meets the criteria for funding. In such cases, patients should be made aware that the assessment does not mean that they will be provided with surgery and surgery will only be provided where it can be demonstrated that the patients meets the criteria to access treatment in this policy. 5. Funding approval will only be given where there is evidence that the treatment requested is effective and the patient has the potential to benefit from the proposed treatment. Where it is demonstrated that patients have previously been provided with the treatment with limited or diminishing benefit, funding approval is unlikely to be agreed. 6. Patients should be advised that receiving funding approval does not confirm that they will receive treatment or surgery for a condition as a consent discussion will need to be undertaken with a clinician prior to treatment. 7. Patients with an elevated BMI of 30 or more are likely to receive fewer benefits from surgery and should be encouraged to lose weight further prior to seeking surgery. In addition, the risks of surgery are significantly increased. (Thelwall, 2015) 8. Patients who are smokers should be referred to smoking cessation services in order to reduce the risk of surgery and improve healing. (Loof S., 2014) 9. Where funding approval is given by the Individual Funding Panel, it will be available for a specified period of time, normally one year. Background This policy is based on the NICE Clinical Guideline 60 published Surgical management of otitis media with effusion in children, with guidance on watchful waiting, requiring a period of 3 months. 2

5 The Cochrane Collaboration evidence review (2010) 2 provides the following conclusions: Evidence suggests that grommets only offer a short-term hearing improvement in children with simple glue ear (otitis media with effusion or OME) who have no other serious medical problems or disabilities. No effect on speech and language development has been shown. Glue ear is the build-up of thick fluid behind the ear drum. It is a common childhood disorder, affecting one or both ears, and is the major cause of transient hearing problems in children. The insertion of grommets (ventilation or tympanostomy tubes) into the ear drum is a surgical treatment option commonly used to improve hearing in children with bilateral glue ear as unilateral glue ear results in minimal, if any, hearing disability. This review found that in children with bilateral glue ear that had not resolved after a period of 12 weeks and was associated with a documented hearing loss, the beneficial effect of grommets on hearing was present at six months but diminished thereafter. Most grommets come out over this time and by then the condition will have resolved in most children. The review did not find any evidence that grommets help speech and language development but no study has been performed in children with established speech, language, learning or developmental problems. Active observation would appear to be an appropriate management strategy for the majority of children with bilateral glue ear as middle ear fluid will resolve spontaneously in most children. Non-surgical interventions The following treatments are not recommended for the management of OME: antibiotics topical or systemic antihistamines topical or systemic decongestants topical or systemic steroids homeopathy cranial osteopathy acupuncture dietary modification, including probiotics immunostimulants massage Autoinflation (OTOVENT) should be considered during the active observation period for children with OME who are likely to cooperate with the procedure. Hearing aids should be offered to children with persistent bilateral OME and hearing loss as an alternative to surgical intervention where surgery is contraindicated or not acceptable. 3

6 In the following circumstances grommets can be undertaken in secondary care and will not require Prior Approval from the CCG: A. 18 years and under with disabilities such as Turners or Down s Syndrome and Cleft Palate where the insertion of the grommets is part of an established pathway of care B. 18 years and under to treat a tympanic membrane retraction pocket POLICY CRITERIA 1 Patients 18 years and under with bilateral Otitis Media with Effusion (OME) and without a secondary disability (such as Down s Syndrome or Cleft Palate) when the following criteria are met: (A and BI or B2) A. The persistence of bilateral OME and hearing loss should be confirmed over a period of 3 months before intervention is considered. The child's hearing should be re-tested at the end of this time AND During the active observation period, advice on educational and behavioural strategies to minimise the effects of hearing loss should be offered auto inflation (eg OTOVENT) has been trialled unless contra - indicated B1. At the end of 3 months the child has persistent bilateral OMEwith a hearing level in the better ear of dbhl or worse averaged at 0.5, 1, 2 and 4 khz (or equivalent dba where dbhl not available) prior approval for Grommet insertion should be requested OR B2. At the end of 3 months the child has persistent bilateral OME with a hearing loss less than dbhl but there is significant impact of the hearing loss on a child's developmental, social or educational status (one of the below) Delay in speech development Poor listening skills Inattention and behavioural problems Educational or behavioural problems attributable to the hearing loss period (the hearing should be retested at the end of this time) 4

7 Patients who are not eligible for treatment under this prior approval policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Applications cannot be considered from patients personally. Provided these patients receive the full support of their general practitioner, or clinician, in pursuing their funding request an application may be made to the Individual Funding Request Panel for consideration. It is expected that clinicians will have ensured that the patient, on behalf of who they are forwarding the application for, is appropriately informed about the existing policies prior to an application to the IFRP. This will reassure the Panel that the patient has a reasonable expectation of the outcome of the application and its context. In order for funding to be agreed there must be some unusual or unique clinical factor about the patient that suggests that they are exceptional as defined below: Significantly different to the general population of patients with the condition in question Likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition If you would like further copies of this policy or need it in another format, such as Braille or another language, please contact the Patient Advice and Liaison Service on Telephone number: Or write to us: NHS Somerset Clinical Commissioning Group, Freepost RRKL- XKSC-ACSG, Yeovil, Somerset, BA22 8HR or us: pals@somersetccg.nhs.uk References 1 NICE CG60 Surgical Management of Otitis Media with Effusion (2008) 2 Browning GG, Rovers MM, Williamson I, Lous J, Burton MJ. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database of Systematic Reviews 2010, Issue 10. Art. No.: CD DOI: / CD pub3. 5